Carboxyamidotriazole Plus Radiation Therapy in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of carboxyamidotriazole plus radiation therapy in treating patients who have newly diagnosed supratentorial glioblastoma multiforme.
Brain and Central Nervous System Tumors
Radiation: radiation therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Clinical and Pharmacologic Study of Radiation Therapy and CAI (Carboxy-amido Triazole) in Adults With Newly Diagnosed Glioblastoma Multiforme|
|Study Start Date:||May 2000|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine overall survival rate and duration of disease free progression in patients with newly diagnosed supratentorial glioblastoma multiforme treated with carboxyamidotriazole and radiotherapy. II. Evaluate the toxicities of this combination regimen in this patient population. III. Determine the correlations between pharmacokinetic parameters and toxicity and/or drug activity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients receive induction therapy consisting of radiotherapy once daily 5 days a week plus oral carboxyamidotriazole once daily for 6 weeks followed by carboxyamidotriazole alone daily for 4 weeks. Patients continue on oral carboxyamidotriazole once daily as maintenance therapy in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for survival.
PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study over 1.5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004146
|United States, Alabama|
|University of Alabama Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294|
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|United States, Georgia|
|Emory University Hospital - Atlanta|
|Atlanta, Georgia, United States, 30322|
|United States, Maryland|
|Johns Hopkins Oncology Center|
|Baltimore, Maryland, United States, 21231|
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|United States, Michigan|
|Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|United States, North Carolina|
|Comprehensive Cancer Center of Wake Forest University Baptist Medical Center|
|Winston-Salem, North Carolina, United States, 27157-1082|
|United States, Pennsylvania|
|University of Pennsylvania Cancer Center|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Texas|
|University of Texas Health Science Center at San Antonio|
|San Antonio, Texas, United States, 78284-7811|
|Study Chair:||Tom Mikkelsen, MD||Josephine Ford Cancer Center at Henry Ford Hospital|